CLASS II Drug recall · Reported 4 Jun 2014 · FDA Enforcement Report
Cefpodoxime Proxetil Tablets, USP, 200 mg recalled by Sandoz
Sandoz is recalling Cefpodoxime Proxetil Tablets, USP, 200 mg, distributed nationwide in the US. The recall was initiated on 22 May 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1350-2014
- FDA event ID
- 68360
- Recalling firm
- Sandoz, Princeton, NJ
- Brand
- Cefpodoxime Proxetil
- Manufacturer
- Sandoz Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2014
- FDA classified
- 23 May 2014
- Reported
- 4 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 22 May 2014 | Recall initiated by company | |
| 23 May 2014 | Classified by FDA | +1 day |
| 4 Jun 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Presence of stainless steel particles.
Product as listed by the FDA
Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20.
Where it was distributed
Nationwide including Puerto Rico.
Questions about this recall
Is Cefpodoxime Proxetil Tablets, USP, 200 mg recalled?
Yes. Sandoz recalled Cefpodoxime Proxetil Tablets, USP, 200 mg on 22 May 2014. The recall is Class II and its status is Terminated. Recall number D-1350-2014.
Why was it recalled?
Presence of Foreign Substance: Presence of stainless steel particles.
Which lots are affected?
Lot #: DZ4056, Expiry: 11/2015; Lot # DZ4057, Expiry: 01/2016
Where was it sold?
Nationwide including Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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